Comparison of Chitodex Gel vs NexFoam on Post-operative Outcomes in the Treatment of Chronic Rhinosinusitis
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy and outcomes of Chitodex gel plus Kenalog versus Nexfoam plus Kenalog in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery. Both dressings are already known to be beneficial in controlling postoperative bleeding and promote wound healing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The trial will be single blinded randomized controlled trial and patients recruited will undergo endoscopic sinus surgery as standard of care for treatment of CRS. Specific outcome measures will be objective and subjective outcome scores post surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Chitogel Chitodex gel plus Kenalog inserted into the middle meatus |
Device: Chitogel
post-operative dressing within standard of care
|
| Nexfoam NexFoam plus Kenalog inserted into the middle meatus |
Device: Nexfoam
post-operative dressing within standard of care
|
Outcome Measures
Primary Outcome Measures
- Clinical Scores on Endoscopy [12 (±2) weeks post surgery]
Outcome measured based on the wound healing in the sinus openings made during surgery.
Secondary Outcome Measures
- Symptom Scores on Patients' Self-Directed Questionnaires [12 (±2) weeks post surgery]
Outcomes measured based on patients' personal symptom assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
-
≥ 18 years to ≤ 90 years AND
-
English speaking AND
-
Able to give written informed consent AND
-
Local residents who will be returning to this center for postoperative follow-up care AND
-
Indicated to undergo endoscopic sinus surgery and willing to return at 2-4, 6-8 & 12 (± 2) weeks post-op.
Exclusion Criteria:
-
allergy to shellfish
-
pregnant or breastfeeding
-
Hepatitis or blood disorders
-
any drug allergy
-
allergy to potato starch (due to Nexfoam)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saint Louis University | Saint Louis | Missouri | United States | 63104 |
Sponsors and Collaborators
- St. Louis University
Investigators
- Principal Investigator: Joseph D Brunworth, MD, Department of Otolaryngology-Head & Neck Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
- Jervis-Bardy J, Boase S, Psaltis A, Foreman A, Wormald PJ. A randomized trial of mupirocin sinonasal rinses versus saline in surgically recalcitrant staphylococcal chronic rhinosinusitis. Laryngoscope. 2012 Oct;122(10):2148-53. doi: 10.1002/lary.23486. Epub 2012 Aug 2.
- Le T, Psaltis A, Tan LW, Wormald PJ. The efficacy of topical antibiofilm agents in a sheep model of rhinosinusitis. Am J Rhinol. 2008 Nov-Dec;22(6):560-7. doi: 10.2500/ajr.2008.22.3232.
- Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.
- 31454